AquaFlate Pre-Filled Sterile Water Syringe 10mL
K-Number: K200556 · 2020-03-31
ApplicantH R Pharmaceuticals, Inc.
Decision Date2020-03-31
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
AquaFlate Pre-Filled Sterile Water Syringe 10mL is a medical device manufactured by H R Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2020-03-31 under approval number K200556. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AquaFlate Pre-Filled Sterile Water Syringe 10mL?
AquaFlate Pre-Filled Sterile Water Syringe 10mL is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by H R Pharmaceuticals, Inc.. The 510(k) number is K200556.
When was AquaFlate Pre-Filled Sterile Water Syringe 10mL approved by the FDA?
AquaFlate Pre-Filled Sterile Water Syringe 10mL received FDA 510(k) clearance on 2020-03-31, under approval number K200556.
What company makes AquaFlate Pre-Filled Sterile Water Syringe 10mL?
AquaFlate Pre-Filled Sterile Water Syringe 10mL is manufactured by H R Pharmaceuticals, Inc..
What is the FDA product code for AquaFlate Pre-Filled Sterile Water Syringe 10mL?
The FDA product code for AquaFlate Pre-Filled Sterile Water Syringe 10mL is EZL.
Other Devices by H R Pharmaceuticals, Inc.
Related Devices (Code: EZL)
K153655Accuryn Monitoring SystemPotrero Medical, Inc.
K161770Rusch Silicone Foley CatheterTeleflexmedical, Inc.
K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.
K181616PSM 3-Way Silicone Foley CatheterPathway, LLC
K180781Bard Vertus Foley CatheterC.R. Bard, Inc.
K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.